Pharma Focus Asia

Titan Pharmaceuticals Presents Non-Clinical Data From Liothyronine (L-T3) Implant Studies

Monday, October 23, 2017

Titan Pharmaceuticals, Inc. announced the planned presentation of non-clinical data on the use of its ProNeura™ subdermal implant for the long-term, sustained delivery of liothyronine (L-T3) during a poster session on Oct. 20 at the 87th annual conference of the American Thyroid Association in Victoria, British Columbia, Canada. The data indicate that these ProNeura implants continuously released L-T3 dose dependently for more than six months, providing important initial in vivo information for the potential development as a treatment of hypothyroidism.

While treatment of hypothyroidism with daily oral levothyroxine (L-T4) alone is effective in most hypothyroid patients, about 15 percent report feeling inadequately treated and are often prescribed a combination of L-T3 with L-T4. A sustained release L-T3 formulation could be an important alternative to combination therapy, as compliance with multiple daily dosing regimens can be challenging.

"We are encouraged by these initial, non-clinical data demonstrating the successful delivery of L-T3 with our ProNeura continuous, long-term drug delivery platform," said Titan Executive Vice President and Chief Development Officer Kate Beebe, PhD. "The results merit further studies to evaluate the potential therapeutic substitution of, or combination with L-T4 for the treatment of hypothyroidism. Additional discussions with endocrinology experts are needed to continue assessment of the product development and regulatory pathways, as well as to further evaluate the market opportunity and potential for collaboration."

In these studies, ProNeura-based L-T3 implants were formulated and tested for release characteristics in several non-clinical models. Pharmacokinetics of T3, T4, and TSH levels were assessed for varying implant doses in serum samples taken pre- and post-implantation. Results showed these L-T3 implants continuously released non-fluctuating levels of T3 dose dependently for over 6 months. The full poster will be available in the publications section of the Titan website following the presentation.

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